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盐酸氟西汀分散片

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盐酸氟西汀分散片盐酸氟西汀分散片 盐酸氟西汀分散片 核准日期:2006年11月12日 修订日期:2008年11月14日 2009年1月24日 药品名称: 【通用名称】 盐酸氟西汀分散片 【商品名称】 百优解? Prozac? ( 百忧解 ) 【英文名称】 Fluoxetine Hydrochloride Dispersible Tablets 【汉语拼音】 Yan Suan Fu Xi Ting Fen San Pian 成份: 盐酸氟西汀 化学名称:(?)-N-甲基-3-苯基-3-[(α、α、α-三氟-P-甲苯基)-氧...
盐酸氟西汀分散片
盐酸氟西汀分散片 盐酸氟西汀分散片 核准日期:2006年11月12日 修订日期:2008年11月14日 2009年1月24日 药品名称: 【通用名称】 盐酸氟西汀分散片 【商品名称】 百优解? Prozac? ( 百忧解 ) 【英文名称】 Fluoxetine Hydrochloride Dispersible Tablets 【汉语拼音】 Yan Suan Fu Xi Ting Fen San Pian 成份: 盐酸氟西汀 化学名称:(?)-N-甲基-3-苯基-3-[(α、α、α-三氟-P-甲苯基)-氧代]丙胺盐酸盐。 化学结构式: 分子式:CHFNO?HCl 17183 分子量:345.79 所属类别: 化药及生物制品 >> 抗精神失常药 >> 抗抑郁药 >> 选择性5-羟色胺再摄取抑制药 性状: 本品为白色椭圆形片。 适应症: 抑郁症 强迫症(OCD) 神经性贪食症:作为心理治疗的辅助用药,以减少贪食和导泻行为 规格: 20 mg(以氟西汀计) 用法用量: 仅用于成人口服 抑郁症 medium above the surface of the pipe and heat, and their spacing is greater than 150mm. Tubing when laid horizontally, should according to different requirement of the 1:10~1:100 slope, tilt should be guaranteed to exclude gas or condensate. 5.1.7.5 angle and u-tube for pressure pipe cards, isolation with a rubber plate, bracket horizontal laying spacing for the 1~1.5M, vertical laying spacing for the 1.5~2m. 5.1.7.6 after you finish laying tubing, should be blowing and pressure testing, air tightness test. 5.1.8 gas pipe laying 5.1.8.1 gas supply system using pipes, valves, fittings, cleaning should be carried out prior to installation, there should be no oil, water, corrosion and dirt. 5.1.8.2 air tubes after cutting, remove end of iron, smooth polished pipe end. Threaded connections, not seal welded, sealed with Teflon tape. Terminal Connection pipes should have a sufficient number of allowances, reduce the effects of vibration and stress. 5.1.8.3 air tube should be used to pipe rack, suitable structures, non-removable device support, terminal be fixed firmly in the 0.9m, bracket 2m. Pipe is not supported on device or process piping: might move or motion of an object, such as heat exchangers, control valves; diameter 3 "pipe, insulation pipe liquid pipe, 1000C, high temperatures of over. 5.1.8.4 dismantling the pipeline in place, should provide a Union. Laid in each pipe, should be installed at least and the possible number of fittings. Perpendicular to the long end of the gas in the pipeline should have a drain valve. 5.1.9 field instrument installation 5.1.9.1 General requirements 5.1.9.1.1 instrument installation according to the design drawings to carefully check their equipment number, type, size and material. 5.1.9.1.2 instrument shall be mounted without mechanical vibration and away from magnetic fields and high 成人及老年患者:每日20 mg,60 mg。推荐的起始剂量为每日20 mg。尽管高剂量可能增加不良反应的发生,但如果治疗3周仍未见效,应考虑增加药物剂量。 WHO达成的共识认为,抗抑郁药物持续治疗至少6个月。 强迫症 成人及老年患者:每日20 mg,60 mg。推荐的起始剂量为每日20 mg。尽管高剂量可能增加不良反应的发生,但如果治疗2周仍未见效,应考虑增加药物剂量。如果治疗10周仍无改善,应考虑换药。如果疗效较好,可根据个体差异调整剂量进行维持治疗。对于氟西汀治疗究竟需要维持多久的问题,尚缺乏系统研究,考虑到OCD是一种慢性疾病,因此对于治疗有效患者推荐维持治疗10周以上。应根据患者个体差异小心调整用药剂量,以最低有效剂量维持治疗。应定期评估是否继续治疗。一些临床医生提倡对于药物治疗有效患者可合并行为治疗。 OCD的长期疗效(超过24周)尚未证实。 神经性贪食症 成人及老年患者:推荐剂量为每日60 mg。 神经性贪食症的长期疗效(超过3月)尚未证实。 所有适应症 推荐剂量可酌情增减。每日剂量高于80 mg的情况未经系统评估。 氟西汀可单次或分次给药,可与食物同服,亦可餐间服用。 停药时,药物活性成分仍将在体内存留数周。这一特点必须在开始及结束治疗时予以考虑。多数患者不需要逐步减少剂量。 儿童:因为安全性和疗效尚未明确,儿童和青少年(不足18岁)不推荐使用氟西汀。 老年人:应注意增加剂量和日剂量一般不宜超过40毫克。最高推荐日剂量为60 mg。 对于肝功能受损患者(参见【药代动力学】),或合用了其它可能产生相互作用(参见【药物相互作用】)药物的患者,需考虑减少剂量或降低给药频率(例如隔日20毫克)。 或遵医嘱。 不良反应: medium above the surface of the pipe and heat, and their spacing is greater than 150mm. Tubing when laid horizontally, should according to different requirement of the 1:10~1:100 slope, tilt should be guaranteed to exclude gas or condensate. 5.1.7.5 angle and u-tube for pressure pipe cards, isolation with a rubber plate, bracket horizontal laying spacing for the 1~1.5M, vertical laying spacing for the 1.5~2m. 5.1.7.6 after you finish laying tubing, should be blowing and pressure testing, air tightness test. 5.1.8 gas pipe laying 5.1.8.1 gas supply system using pipes, valves, fittings, cleaning should be carried out prior to installation, there should be no oil, water, corrosion and dirt. 5.1.8.2 air tubes after cutting, remove end of iron, smooth polished pipe end. Threaded connections, not seal welded, sealed with Teflon tape. Terminal Connection pipes should have a sufficient number of allowances, reduce the effects of vibration and stress. 5.1.8.3 air tube should be used to pipe rack, suitable structures, non-removable device support, terminal be fixed firmly in the 0.9m, bracket 2m. Pipe is not supported on device or process piping: might move or motion of an object, such as heat exchangers, control valves; diameter 3 "pipe, insulation pipe liquid pipe, 1000C, high temperatures of over. 5.1.8.4 dismantling the pipeline in place, should provide a Union. Laid in each pipe, should be installed at least and the possible number of fittings. Perpendicular to the long end of the gas in the pipeline should have a drain valve. 5.1.9 field instrument installation 5.1.9.1 General requirements 5.1.9.1.1 instrument installation according to the design drawings to carefully check their equipment number, type, size and material. 5.1.9.1.2 instrument shall be mounted without mechanical vibration and away from magnetic fields and high 随着本品的持续治疗,不良反应的强度和发生频率会减少,通常不会导致治疗停止。 同其它SSRIs一样,常见的不良反应如下: 全身:过敏(如搔痒、皮疹、风疹、过敏反应、脉管炎、血清反应、颜面水肿等)(见【禁忌】和【警告】)、寒战、5-羟色胺综合征、光敏反应及非常罕见的情况下,多形性红斑有可能发展为斯-约二氏综合征或中毒性表皮坏死松解症(Lyell综合征)。 消化系统:胃肠道功能紊乱(如腹泻、恶心、呕吐、消化不良、吞咽困难、味觉颠倒)、口干等。少见肝功能检测异常,肝炎鲜有报告。 神经系统:头痛、睡眠异常(如梦境反常、失眠、困倦)、头晕、厌食、疲乏、欣快、短暂的动作异常(如抽搐、共济失调、战栗、肌阵挛等)、痉挛发作及罕见的精神运动性不安/静坐不能(见【注意事项】)。5-羟色胺综合征非常罕见。 精神科障碍:幻觉,躁狂反应,意识错乱,激越,焦虑及有关症状(如紧张),注意力及思考能力减弱(如,人格解体),惊恐发作,五羟色胺综合征极罕见,自杀观念和行为(这些症状可以是由于潜在疾病造成的)。在氟西汀治疗过程中或治疗停止后早期报告有自杀观念和自杀行为(见【注意事项】)。 泌尿系统:尿潴留,尿频等。 生殖紊乱:性功能障碍(如延迟或缺少射精、性高潮缺乏)、阴茎异常勃起、溢乳。 其它症状:脱发、呵欠、视觉异常(如视力模糊,瞳孔散大等)、出汗、血管舒张、关节痛、肌痛、体位性低血压和瘀癍。其它出血表现(如妇科出血、胃肠道出血和其他皮肤或粘膜出血)罕见报告(详见【注意事项】:出血)。 一过性低血钠:停服本品时极少数患者出现一过性低血钠(包括血钠低于110 mmol/L),且可逆。某些病例可能是由于抗利尿激素分泌失调引起。多数报道见于老年人、服用利尿药的患者、或其它原因导致体液耗竭的患者。 呼吸系统:咽炎和呼吸困难。肺的不良事件罕见(包括组织病理学的炎性变化和/或纤维化)。呼吸困难可能是最初唯一的症状。 氟西汀治疗停止时的撤药症状:氟西汀的停药通常会产生撤药症状。头晕,感觉障碍(包括感觉异常),睡眠障碍(包括失眠和多梦),乏力,激越或焦虑,恶心和,或呕吐,震颤和头痛足最常报告的不良反应。一般这些症状足轻度剑中度井且是自限的,然而在一些患者中这些症状可能很严重和,或延长缓解时间(见【注意事项】)。因此,当百优解治疗需要停止时,建议逐渐地减少剂量(见【用法用量】和【注意事项)。 儿童和青少年(参见【注意事项】) medium above the surface of the pipe and heat, and their spacing is greater than 150mm. Tubing when laid horizontally, should according to different requirement of the 1:10~1:100 slope, tilt should be guaranteed to exclude gas or condensate. 5.1.7.5 angle and u-tube for pressure pipe cards, isolation with a rubber plate, bracket horizontal laying spacing for the 1~1.5M, vertical laying spacing for the 1.5~2m. 5.1.7.6 after you finish laying tubing, should be blowing and pressure testing, air tightness test. 5.1.8 gas pipe laying 5.1.8.1 gas supply system using pipes, valves, fittings, cleaning should be carried out prior to installation, there should be no oil, water, corrosion and dirt. 5.1.8.2 air tubes after cutting, remove end of iron, smooth polished pipe end. Threaded connections, not seal welded, sealed with Teflon tape. Terminal Connection pipes should have a sufficient number of allowances, reduce the effects of vibration and stress. 5.1.8.3 air tube should be used to pipe rack, suitable structures, non-removable device support, terminal be fixed firmly in the 0.9m, bracket 2m. Pipe is not supported on device or process piping: might move or motion of an object, such as heat exchangers, control valves; diameter 3 "pipe, insulation pipe liquid pipe, 1000C, high temperatures of over. 5.1.8.4 dismantling the pipeline in place, should provide a Union. Laid in each pipe, should be installed at least and the possible number of fittings. Perpendicular to the long end of the gas in the pipeline should have a drain valve. 5.1.9 field instrument installation 5.1.9.1 General requirements 5.1.9.1.1 instrument installation according to the design drawings to carefully check their equipment number, type, size and material. 5.1.9.1.2 instrument shall be mounted without mechanical vibration and away from magnetic fields and high 在儿科临床试验中,抗抑郁药物治疗组较安慰剂对照组较多发生自杀相关行为(自杀企图和自杀想法)和敌对性行为。 长期使用氟西汀超过19刷的安全性没有系统研究。 在儿科临床试验中,有关于躁狂和轻躁狂的反应的报告(氟西汀2.6%,安慰剂组O%),多数导致停药。这些患者既往没有躁狂和轻躁狂的病史。 在一项儿科临床试验中,服药19周后,氟西汀组的身高增长较安慰剂对照组少l.lcm (p=0.004),体重增长较安慰剂对照组少l.lkg (p=0.008)。临床应用中有关于生长发育迟缓的个别病例报告。 百优解用于儿童有过性成熟发育延迟或性功能障碍的个别病例报告。(参见 【药理毒理】) 在儿科临床试验中还发现服用氟西汀伴随碱性磷睃酶水平降低。 禁忌: 对氟西汀或其辅料成份过敏患者禁用。 :有报告在接受选择性5-羟色胺再摄取抑制剂(SSRI)治疗的单胺氧化酶抑制剂(MAOI) 患者同时合并单胺氧化酶抑制剂(MAOI),以及近期终止SSRI治疗转而开始单胺氧化酶抑制剂治疗的患者中间出现严重的、有时甚至是致命的反应。氟西汀的治疗必须在不可逆的MAOI停药2周之后开始。 有些病例可表现出类似5-羟色胺综合征(类似神经阻滞剂恶性综合症并可能被作出如此诊断)的特点。赛庚啶或丹曲林可能会对此类病人的治疗有益。合用MAOI的患者出现的反应包括:高热、僵硬、肌阵挛、自主神经系统不稳定伴有生命体征的迅速波动、以及精神状态的变化,包括极度的激越,可能发展为谵妄和昏迷。 因此,氟西汀不宜与非选择性MAOI合并使用。同样,至少应在停用本药5周后,方可开始使用MAOI。如果氟西汀长期使用和/或服用剂量较高时,可能需要更长的时间方可开始单胺氧化酶抑制剂治疗。 不推荐合用可逆性MAOI(例如吗氯贝胺)。氟西汀的治疗可以在可逆性MAOI停药后第二天开始。 注意事项: 警告 未满18周岁的儿童和青少年 在临床试验中,抗抑郁药治疗组与安慰剂对照组相比较,更容易发生自杀相关行为(自杀企图和自杀想法),敌对行为((主要是攻击、对立行为和发怒)。百优解只适用于治疗8岁至18周岁儿童和青少年的中重度抑郁发作,不用于其它适应症。如果根据临床需要应当medium above the surface of the pipe and heat, and their spacing is greater than 150mm. Tubing when laid horizontally, should according to different requirement of the 1:10~1:100 slope, tilt should be guaranteed to exclude gas or condensate. 5.1.7.5 angle and u-tube for pressure pipe cards, isolation with a rubber plate, bracket horizontal laying spacing for the 1~1.5M, vertical laying spacing for the 1.5~2m. 5.1.7.6 after you finish laying tubing, should be blowing and pressure testing, air tightness test. 5.1.8 gas pipe laying 5.1.8.1 gas supply system using pipes, valves, fittings, cleaning should be carried out prior to installation, there should be no oil, water, corrosion and dirt. 5.1.8.2 air tubes after cutting, remove end of iron, smooth polished pipe end. Threaded connections, not seal welded, sealed with Teflon tape. Terminal Connection pipes should have a sufficient number of allowances, reduce the effects of vibration and stress. 5.1.8.3 air tube should be used to pipe rack, suitable structures, non-removable device support, terminal be fixed firmly in the 0.9m, bracket 2m. Pipe is not supported on device or process piping: might move or motion of an object, such as heat exchangers, control valves; diameter 3 "pipe, insulation pipe liquid pipe, 1000C, high temperatures of over. 5.1.8.4 dismantling the pipeline in place, should provide a Union. Laid in each pipe, should be installed at least and the possible number of fittings. Perpendicular to the long end of the gas in the pipeline should have a drain valve. 5.1.9 field instrument installation 5.1.9.1 General requirements 5.1.9.1.1 instrument installation according to the design drawings to carefully check their equipment number, type, size and material. 5.1.9.1.2 instrument shall be mounted without mechanical vibration and away from magnetic fields and high 给予百优解治疗,在治疗过程中应小心观察自杀性症状的表现。涉及青少年长期用药安全性(包括对生长发育、性成熟、认知、情感和行为的发展影响)的资料很有限。(见【药理毒理】) 在一个为期19周的临床研究中发现,服用氟西汀减少青少年的身高和体重增加(见【不良反应】)。尚未确定氟西汀足否影响这些人达到正常成年人的身高。氟西汀对青春期发育影响的可能性不能排除(见【药理毒理】和【不良反应】)。在治疗过程中及治疗后应注意监测青少年的成长发育指标(包括身高、体重和TANNER发育阶段)。如发现其中某项落后于正常发育,应转诊儿科医生处理。 在儿科的临床试验中常发现躁狂和轻度躁狂病例(见【不良反应】)。建议对躁狂和轻度的躁狂的发生进行定期监查。如发生躁狂,立即停药。 医生在处方时应详细与儿童,青少年患者和,或其父母讨论治疗的利弊。 皮疹初过敏反应:皮疹、过敏反应和进一步的全身反应,有时非常常严重(包括皮肤、肾脏、肝脏和肺)。如果出现皮疹或其它可能的过敏现象而不能确定病因时,应停用氟西汀。 注意 抽搐发作:对抗抑郁药而言,抽搐发作是一个潜在的危险。因此,同其它抗抑郁药一样,氟西汀须慎用于既往有抽搐发作史的患者。患者发生抽搐发作或抽搐发作频率增加,应立即停药。氟西汀应避免用于不稳定性抽搐发作,癫痫患者,如用于癫痫控制稳定的患者,则应加强监护。 狂躁症:抗抑郁药应慎用于既往有躁狂,轻躁狂病史的患者。同所有抗抑郁药一样,一旦患者发生躁狂,应立即停药。 肝/肾功能:氟西汀主要经肝脏代谢,通过肾脏排泄。对于严重肝功能紊乱的患者,应降低服用量,如隔日给药。连续给约2个月(每日20 mg)后,需要透析的严重肾衰患者(肾小球滤过率GFR<10 ml/min)与肾功能正常的对照者相比,血浆中氟西汀和去甲氟西汀水平无差异。 心脏疾病:在一项双盲试验中对312例服用本品患者的心电图进行评估,未发现心脏传导阻滞。然而,对于急性心脏疾病患者服用本品的临床经验尚有限,因此此类患者应慎用。 体重减轻:氟匹汀可能导致体重减轻,但通常与基线体重成比例。 糖尿病:糖尿病患者服用SSRI可影Ilf4血糖浓度。服用氟西汀期间可能出现低血糖,停药后继而出现高血糖。应调够胰岛素和口服降糖药的剂量。 medium above the surface of the pipe and heat, and their spacing is greater than 150mm. Tubing when laid horizontally, should according to different requirement of the 1:10~1:100 slope, tilt should be guaranteed to exclude gas or condensate. 5.1.7.5 angle and u-tube for pressure pipe cards, isolation with a rubber plate, bracket horizontal laying spacing for the 1~1.5M, vertical laying spacing for the 1.5~2m. 5.1.7.6 after you finish laying tubing, should be blowing and pressure testing, air tightness test. 5.1.8 gas pipe laying 5.1.8.1 gas supply system using pipes, valves, fittings, cleaning should be carried out prior to installation, there should be no oil, water, corrosion and dirt. 5.1.8.2 air tubes after cutting, remove end of iron, smooth polished pipe end. Threaded connections, not seal welded, sealed with Teflon tape. Terminal Connection pipes should have a sufficient number of allowances, reduce the effects of vibration and stress. 5.1.8.3 air tube should be used to pipe rack, suitable structures, non-removable device support, terminal be fixed firmly in the 0.9m, bracket 2m. Pipe is not supported on device or process piping: might move or motion of an object, such as heat exchangers, control valves; diameter 3 "pipe, insulation pipe liquid pipe, 1000C, high temperatures of over. 5.1.8.4 dismantling the pipeline in place, should provide a Union. Laid in each pipe, should be installed at least and the possible number of fittings. Perpendicular to the long end of the gas in the pipeline should have a drain valve. 5.1.9 field instrument installation 5.1.9.1 General requirements 5.1.9.1.1 instrument installation according to the design drawings to carefully check their equipment number, type, size and material. 5.1.9.1.2 instrument shall be mounted without mechanical vibration and away from magnetic fields and high 自杀,自杀观念或临床恶化:抑郁与患者自杀意念、自伤行为以及自杀(自杀相关事件)等危险的发生率增加有关。这种危险持续存在,直至症状显著缓解。由于在治疗的最初几周内或更长的时间疗效可能不明显,因此在此期间应该密切监护患者,直至症状明显好转。临床经验表明,在康复的最初阶段,自杀的风险可能会增加。 当百优解用于其他适应症时,也有可能增加自杀相关事件的发生率。而这些事件的发生有可能与严重抑郁发作疾病状态同时存在。因此,百优解用与治疗抑郁症时所遵循的预防自杀的措施,同样适用于治疗其他适应症。 那些有自杀相关事件病史,在接受治疗之前就存在明显自杀观念的患者,发生自杀想法和自杀企图的危险率更高,在治疗中应密切观察。对一项患有精神疾病的成年患者中进行的安慰剂对照的抗抑郁药临床试验进行荟萃分析,结果显示在小于25周岁的患者中抗抑郁药组相比安慰剂对照组发生自杀行为的风险增加。 密切监护患者(尤其是高风险的患者,并应该联合药物治疗,尤其是在早期治疗和接下来剂量调整时。患者(及其护理者)应该警惕任何临床恶化、自杀行为或观念及行为的异常改变,如果出现这些症状应立即就诊。 静坐不能,精神运动性不安:使用氟西汀有可能伴随静坐不能的症状,特征是主观体验到不快或痛苦的不安,需要走动,常伴有能静坐或静立。上述情况最常发生于治疗的最初几周,发生此类症状的患者,如增加剂量可能会加重症状。 SSRI治疗停止后的撤药症状:停约时发生撤药反应比较普遍,尤见于突然停药(见【不良反心】)。临床试验中,在氟西汀组和安慰剂组跟撤药有关的不良事件发生率都是约60%。其中氟西汀组17%,安慰剂组12%比较严重。 停药反应发生的风险与几个因素有关,包括治疗剂量、周期和减量速度。常见的停药反应包括头晕、感觉障碍(包括感觉异常),睡眠障碍(失眠和多梦)、衰弱、激越或焦虑,恶心和/或呕吐,震颤,以及头痛。多数病人症状为轻中度,但部分病人可能症状较重。停药反应通常发生停药的前几天内。症状一般具有自限性,通常会在停药两周内缓解,部分病人可能会迁延不愈(2,3个月或更长)。根据患者的需求,建议应当至少1,2周内逐渐减少百优解用量最终停药。(参见【不良反应】和【用法用量】)。 出血:已有报道,服用SSRI患者出现皮肤出血,例如瘀癍和紫癜。在服用氟西汀患者中,瘀癍少有报告。其它出血症状(例如妇科出血、胃肠道出血及其它皮肤或粘膜出血)罕见报告。需要提醒注意的是服用SSRI患者,尤其是合用口服抗凝血药、已知影响血小板功能药物(例如非典型抗精神病药——氯氮平、吩噻嗪类、大多数三环类抗抑郁药、阿司匹林、非甾体类抗炎药)或其他能增加出血可能性的药物的患者,以及既往有出血史的患者,应加强监控。 电抽搐治疗:服州氟西的患者接受电抽搐治疗时惊厥时间延长的情况鲜有报告,但也须谨慎。 medium above the surface of the pipe and heat, and their spacing is greater than 150mm. Tubing when laid horizontally, should according to different requirement of the 1:10~1:100 slope, tilt should be guaranteed to exclude gas or condensate. 5.1.7.5 angle and u-tube for pressure pipe cards, isolation with a rubber plate, bracket horizontal laying spacing for the 1~1.5M, vertical laying spacing for the 1.5~2m. 5.1.7.6 after you finish laying tubing, should be blowing and pressure testing, air tightness test. 5.1.8 gas pipe laying 5.1.8.1 gas supply system using pipes, valves, fittings, cleaning should be carried out prior to installation, there should be no oil, water, corrosion and dirt. 5.1.8.2 air tubes after cutting, remove end of iron, smooth polished pipe end. Threaded connections, not seal welded, sealed with Teflon tape. Terminal Connection pipes should have a sufficient number of allowances, reduce the effects of vibration and stress. 5.1.8.3 air tube should be used to pipe rack, suitable structures, non-removable device support, terminal be fixed firmly in the 0.9m, bracket 2m. Pipe is not supported on device or process piping: might move or motion of an object, such as heat exchangers, control valves; diameter 3 "pipe, insulation pipe liquid pipe, 1000C, high temperatures of over. 5.1.8.4 dismantling the pipeline in place, should provide a Union. Laid in each pipe, should be installed at least and the possible number of fittings. Perpendicular to the long end of the gas in the pipeline should have a drain valve. 5.1.9 field instrument installation 5.1.9.1 General requirements 5.1.9.1.1 instrument installation according to the design drawings to carefully check their equipment number, type, size and material. 5.1.9.1.2 instrument shall be mounted without mechanical vibration and away from magnetic fields and high 圣•约翰草:当选择性5-羟色胺再摄取抑制剂(SSRI)和包括圣•约翰草(金丝桃素)和内的的草本制剂合用时,可能会增加5-羟色胺能效应,如5-羟色胺综合征。 氟西汀治疗时,尤其是合用5-羟色胺能药物(包括L-色氨酸)和,或抗精神病药时,极少情况下会出跳5-羟色胺综合征或类似神经阻滞剂恶性综合征。由于这些情况己(临床症状群表现为高热、僵硬、肌阵挛、自主神经系统不稳定伴有生命体征的迅速波动、以及精神状态的变化,后者包括意识错乱、易激惹、极度激越直至发展为谵妄和昏迷)可能危及生命,故遇到这种情况发生,应立即终止氟西汀治疗并给予对症支持治疗。 因该制剂中用了山梨醇,罕见的遗传性果糖不耐受的病人禁用。 对驾车和机械操作的影响 尽管未发现氟西汀会影响健康志愿者的精神运动行为,但任何精神活性药物郝都可能影响人的判断能力及技能。因此应告诫患者避免驾车或操作危险性的机械,直至患者相当确信他们的行为不受影响。 孕妇及哺乳期妇女用药: 大量资料显示氟西汀对人类并无致畸作用。氟西汀在怀孕期间可以使用,但需注意,孕妇: 尤其在妊娠晚期或分娩开始时。因为已有报道氟西汀对新生儿产生以下影响:易激惹、震颤、肌张力减退、持续哭泣、吮吸困难或睡眠困难。这些症状提示可能是5-羟色胺能效应或撤药综合征。这些症状发生和持续的时间可能与氟西汀(4,6天)及其活性代谢产物去甲氟西汀(4,16天)较长的半衰期有关。 乳母:氟西汀及其代谢产物去甲氟西汀可分泌至母乳。对乳儿的不良事件已有报道。如果必需服用氟西汀,应停止母乳喂养;但是,如果要继续母乳喂养,氟西汀应采用最低有效剂量。 儿童用药: 由于尚未明确啊在儿童和青少年(18岁以下)中使用的安全及疗效,因此不推荐在该人群中使用。 老年用药: 增加剂量应当谨慎,日剂量一般不宜超过40 mg。最高推荐日剂量为60 mg。见【用法用量】。 药物相互作用: 0. 药物相互作用仅对成年人进行了研究。 半衰期:分析药物间在药效动力学和药代动力学上的相互作用时(例如从氟西汀换用其它抗抑郁药时)应考虑氟西汀和去甲氟西汀较长的消除半衰期(详见【药代动力学】)。 单胺氧化酶抑制剂:(参见【禁忌】)。 配伍禁忌:MAOI-A(参见【禁忌】) medium above the surface of the pipe and heat, and their spacing is greater than 150mm. Tubing when laid horizontally, should according to different requirement of the 1:10~1:100 slope, tilt should be guaranteed to exclude gas or condensate. 5.1.7.5 angle and u-tube for pressure pipe cards, isolation with a rubber plate, bracket horizontal laying spacing for the 1~1.5M, vertical laying spacing for the 1.5~2m. 5.1.7.6 after you finish laying tubing, should be blowing and pressure testing, air tightness test. 5.1.8 gas pipe laying 5.1.8.1 gas supply system using pipes, valves, fittings, cleaning should be carried out prior to installation, there should be no oil, water, corrosion and dirt. 5.1.8.2 air tubes after cutting, remove end of iron, smooth polished pipe end. Threaded connections, not seal welded, sealed with Teflon tape. Terminal Connection pipes should have a sufficient number of allowances, reduce the effects of vibration and stress. 5.1.8.3 air tube should be used to pipe rack, suitable structures, non-removable device support, terminal be fixed firmly in the 0.9m, bracket 2m. Pipe is not supported on device or process piping: might move or motion of an object, such as heat exchangers, control valves; diameter 3 "pipe, insulation pipe liquid pipe, 1000C, high temperatures of over. 5.1.8.4 dismantling the pipeline in place, should provide a Union. Laid in each pipe, should be installed at least and the possible number of fittings. Perpendicular to the long end of the gas in the pipeline should have a drain valve. 5.1.9 field instrument installation 5.1.9.1 General requirements 5.1.9.1.1 instrument installation according to the design drawings to carefully check their equipment number, type, size and material. 5.1.9.1.2 instrument shall be mounted without mechanical vibration and away from magnetic fields and high 合用时注意事项: MAOI-B(司来吉兰):5-羟色胺综合征风险,建议临床监查。 苯妥英钠:当与氟西汀合用时已发现血药浓度存在变化。在一些病例中已有毒性反应报道。如果需要合用此药物,建议采用保守的剂量调整策略并监查临床状态。 5-羟色胺激动剂:本品与5-羟色胺激动剂(如5-羟色胺去甲肾上腺素再摄取抑制剂(SNRIs),选择性5-羟色胺再摄取抑制剂(SSRIs),曲马多、曲坦类)合用,可能增加5-羟色胺综合征的风险。合用曲坦类时增加冠状动脉痉挛和高血压发生的危险性。 锂盐和色氨酸:有报告指出,锂盐和色氨酸与SSRIs合用时,可出现5-羟色胺综合征。当本品与这些药物合用时应十分小心。当氟西汀与锂盐合用时,需要更加细致和频繁的监查。 CYP2D6酶:与三环类抗抑郁药及其它选择性5-羟色胺类抗抑郁药类似,氟西汀经肝细胞色素CYP2D6同功酶系统代谢,因此,同样经该酶系统代谢的药物可能导致药物相互作用。若合用其它主要经由此同功酶代谢的药物,且治疗窗很窄(例如氟卡胺、恩卡胺、卡马西平及三环类抗抑郁药),其起始剂量应降低或将治疗剂量调至治疗范围下限。如果最近5周内曾服用氟西汀,该原则同样适用。 口服抗凝剂:偶见报告,氟西汀与口服抗凝剂合用时,抗凝作用发生变化(试验数据和/或临床症状体征),类型不一,但都包括增加出血症状。正在服用华法令的患者在起始或停止氟西汀治疗时应接受仔细的凝血状况监测(详见【注意事项】:出血)。 电抽搐治疗(ECT):服用氟西汀的患者接受电抽搐治疗时惊厥时间延长的情况鲜有报道,但也须谨慎。 乙醇:正规试验中,本品不提高血中乙醇水平或增强乙醇作用。然而,不推荐SSRI治疗与乙醇合用。 圣•约翰草:同其它SSRIs一样,本品和草药圣•约翰草(金丝桃素)可能发生药效学相互作用,这会导致不良反应增加。 药物过量: 单独过量服用氟西汀通常症状比较轻微。过量的症状包括恶心、呕吐、痉挛发作、心血管功能失调(从无症状的心律不齐到心搏停止)、肺功能障碍和中枢神经系统功能紊乱(从兴奋到昏迷)。单独过量服用本品导致死亡的报告极其罕见。建议立刻停药,监测心脏和生命体征,辅以一般对症和支持治疗。对本品无特效解毒药。 强制利尿、透析、血液灌注和体液交换等方法均不理想。合用活性炭和山梨醇的疗效与催吐及洗胃相同,甚至更好。处理过量服药时,须考虑同时服用多种药物的可能性。近期曾经服用或正在服用本品的患者同时服用了过量的三环类药物,应密切观察并延长观察期。 临床试验: medium above the surface of the pipe and heat, and their spacing is greater than 150mm. Tubing when laid horizontally, should according to different requirement of the 1:10~1:100 slope, tilt should be guaranteed to exclude gas or condensate. 5.1.7.5 angle and u-tube for pressure pipe cards, isolation with a rubber plate, bracket horizontal laying spacing for the 1~1.5M, vertical laying spacing for the 1.5~2m. 5.1.7.6 after you finish laying tubing, should be blowing and pressure testing, air tightness test. 5.1.8 gas pipe laying 5.1.8.1 gas supply system using pipes, valves, fittings, cleaning should be carried out prior to installation, there should be no oil, water, corrosion and dirt. 5.1.8.2 air tubes after cutting, remove end of iron, smooth polished pipe end. Threaded connections, not seal welded, sealed with Teflon tape. Terminal Connection pipes should have a sufficient number of allowances, reduce the effects of vibration and stress. 5.1.8.3 air tube should be used to pipe rack, suitable structures, non-removable device support, terminal be fixed firmly in the 0.9m, bracket 2m. Pipe is not supported on device or process piping: might move or motion of an object, such as heat exchangers, control valves; diameter 3 "pipe, insulation pipe liquid pipe, 1000C, high temperatures of over. 5.1.8.4 dismantling the pipeline in place, should provide a Union. Laid in each pipe, should be installed at least and the possible number of fittings. Perpendicular to the long end of the gas in the pipeline should have a drain valve. 5.1.9 field instrument installation 5.1.9.1 General requirements 5.1.9.1.1 instrument installation according to the design drawings to carefully check their equipment number, type, size and material. 5.1.9.1.2 instrument shall be mounted without mechanical vibration and away from magnetic fields and high 抑郁症:多项针对抑郁症患者进行的安慰剂和活性药物对照临床试验中,以汉密顿抑郁量表(HAM-D)作为评估工具,已证实氟西汀疗效明显优于安慰剂。在这些研究中,氟西汀的有效率(指HAM-D评分减少50%)和缓解率显著高于安慰剂。 强迫症:短期试验(少于24周)显示氟西汀比安慰剂更有效。治疗剂量为每日20 mg,但是高剂量(每日40或60 mg)有效率更高。长程研究结果(三项短期研究的延续阶段和一项预防复发研究)并未发现这种疗效。 神经性贪食症:短程研究(少于16周)显示,在符合DSM-III-R神经性贪食症诊断标准的门诊患者中,氟西汀每日60 mg治疗贪食和导泻的疗效显著优于安慰剂。然而长程疗效尚未确定。 两项针对符合DSM - IV月经前焦虑障碍(PMDD)诊断标准的患者的安慰剂对照研究中,将症状较重、导致其社会和职业功能及人际交往能力受损的患者选入研究,排除口服避孕药者。第一项研究中,连续给予氟西汀每日20毫克治疗6个月经周期,主要疗效指标(易激惹、焦虑和恶劣心境)获得改善。第二项研究中,在黄体期间断给药(每日20毫克,14天)3个月经周期,主要疗效指标(问题严重度每日记录分值)也获得改善。但是,仅根据上述研究尚不能得出疗效和疗程的确切结论。 药理毒理: 氟西汀是一种选择性5-羟色胺再摄取抑制剂,这可能解释其作用机理。氟西汀对其它受体,如α1-,α2-,和β肾肾上腺素能;5一羟色胺能;多巴胺能;组胺能1;毒蕈碱能:GABA受体几乎没有结合力。 体外和动物试验片未发现本品具有致癌、致突变或生殖损害作用。 药代动力学: 吸收-- 氟西汀口服后从胃肠道吸收良好。进食不影响其生物利用度。 分布-- 氟西汀与血浆蛋白大量结合(约95%),分布广泛(表观分布容积20,40 l/kg)。服药数周后达到稳态血浆浓度。连续服药后的稳态血浆浓度同服药4,5周时相似。 代谢-- 氟西汀符合有肝脏首过效应的非线性药代动力学方程。服药后6,8小时达到血浆峰浓度。 氟西汀主要经多态的CYP2D6酶代谢。氟西汀基本由肝脏代谢,通过去甲基化作用生成活性代谢产物去甲氟西汀(demethylfluoxetine)。 清除-- 氟西汀的消除半衰期为4,6天,而去甲氟西汀则为4,16天。较长的半衰期使得停药后仍能维持5,6周的疗效。本品主要(大约60%)经肾脏排泄。氟西汀可分泌至母乳。 高危人群 ?老年人:健康老人和年轻受试者比较,药代动力学参数没有改变。 ?肝功能不全者:肝功能不全(酒精性肝硬化)者中氟西汀和去甲氟西汀的半衰期分别增加medium above the surface of the pipe and heat, and their spacing is greater than 150mm. Tubing when laid horizontally, should according to different requirement of the 1:10~1:100 slope, tilt should be guaranteed to exclude gas or condensate. 5.1.7.5 angle and u-tube for pressure pipe cards, isolation with a rubber plate, bracket horizontal laying spacing for the 1~1.5M, vertical laying spacing for the 1.5~2m. 5.1.7.6 after you finish laying tubing, should be blowing and pressure testing, air tightness test. 5.1.8 gas pipe laying 5.1.8.1 gas supply system using pipes, valves, fittings, cleaning should be carried out prior to installation, there should be no oil, water, corrosion and dirt. 5.1.8.2 air tubes after cutting, remove end of iron, smooth polished pipe end. Threaded connections, not seal welded, sealed with Teflon tape. Terminal Connection pipes should have a sufficient number of allowances, reduce the effects of vibration and stress. 5.1.8.3 air tube should be used to pipe rack, suitable structures, non-removable device support, terminal be fixed firmly in the 0.9m, bracket 2m. Pipe is not supported on device or process piping: might move or motion of an object, such as heat exchangers, control valves; diameter 3 "pipe, insulation pipe liquid pipe, 1000C, high temperatures of over. 5.1.8.4 dismantling the pipeline in place, should provide a Union. Laid in each pipe, should be installed at least and the possible number of fittings. Perpendicular to the long end of the gas in the pipeline should have a drain valve. 5.1.9 field instrument installation 5.1.9.1 General requirements 5.1.9.1.1 instrument installation according to the design drawings to carefully check their equipment number, type, size and material. 5.1.9.1.2 instrument shall be mounted without mechanical vibration and away from magnetic fields and high 到7天和12天。须考虑减少药物剂量或降低用药频率。 ?肾功能不全者:轻、中、重度(无尿)肾功能不全患者单次服用氟西汀的药代动力学参数 和健康志愿者比较无差异。然而,重复给药后,可见稳态血浆峰浓度增加。 贮藏: 室温(15,25?)保存。 包装: 铝塑包装,7片,14片,28片/盒。 有效期: 24个月 执行标准: 进口药品注册标准JX20080047 批准文号: 国药准字J20050122 进口药品注册证号: H20080623 H20080624 生产企业: PATHEON FRANCE 包装企业: 礼来苏州制药有限公司 medium above the surface of the pipe and heat, and their spacing is greater than 150mm. Tubing when laid horizontally, should according to different requirement of the 1:10~1:100 slope, tilt should be guaranteed to exclude gas or condensate. 5.1.7.5 angle and u-tube for pressure pipe cards, isolation with a rubber plate, bracket horizontal laying spacing for the 1~1.5M, vertical laying spacing for the 1.5~2m. 5.1.7.6 after you finish laying tubing, should be blowing and pressure testing, air tightness test. 5.1.8 gas pipe laying 5.1.8.1 gas supply system using pipes, valves, fittings, cleaning should be carried out prior to installation, there should be no oil, water, corrosion and dirt. 5.1.8.2 air tubes after cutting, remove end of iron, smooth polished pipe end. Threaded connections, not seal welded, sealed with Teflon tape. Terminal Connection pipes should have a sufficient number of allowances, reduce the effects of vibration and stress. 5.1.8.3 air tube should be used to pipe rack, suitable structures, non-removable device support, terminal be fixed firmly in the 0.9m, bracket 2m. Pipe is not supported on device or process piping: might move or motion of an object, such as heat exchangers, control valves; diameter 3 "pipe, insulation pipe liquid pipe, 1000C, high temperatures of over. 5.1.8.4 dismantling the pipeline in place, should provide a Union. Laid in each pipe, should be installed at least and the possible number of fittings. Perpendicular to the long end of the gas in the pipeline should have a drain valve. 5.1.9 field instrument installation 5.1.9.1 General requirements 5.1.9.1.1 instrument installation according to the design drawings to carefully check their equipment number, type, size and material. 5.1.9.1.2 instrument shall be mounted without mechanical vibration and away from magnetic fields and high
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